Consumers, patients and clinicians, who use or recommend herbal supplements as a part of an integrative approach to healthcare, all face the same dilemma: confidence in herbal supplements has eroded in recent years. This has happened, in part, because of continued negative reports in the media (some erroneous and biased, some warranted). Safety seems to be a key question. In the face of concerns about safety and the preference for additional safety information on the labels of herbal supplements, Pharmavite Corporation approached the American Botanical Council (ABC) to request the development of a program to address these concerns. As a result of this collaboration, ABC launched its Safety Labeling Program (SLP), a program that provides expanded safety information for manufacturers. Pharmavite Corporation is using the SLP information on its Nature’s Resource^® herbal product labels in a new program called Herbal ABCs^™.

ABC’s Safety Labeling Program

To help bring greater clarity to the safe use of herbs (including potential interactions, adverse effects, and contraindications), and through consumer research, suggestions, and initial funding by Pharmavite, ABC initiated SLP to provide some guidance in this area. SLP provides science-based safety information on specific herbs for manufacturers to use as a basis to develop product labels (see How SLP works, below). This program will benefit consumers and patients, who need more information about the herbs they use, and healthcare professionals, who can use such information to help assess the potential risk and appropriate use of many popular herbs.

First use of SLP

Pharmavite Corporation, which produces Nature’s Resource herbs, a brand marketed in mass-market locations, worked with ABC to develop the SLP and is the first company to print expanded label information based on ABC’s research and bear the ABC logo. By the end of 2003, approximately 4 million labels on 21 Nature’s Resource products will contain peel-back, multi-page safety text based on information provided by ABC. Other manufacturers are also considering participation in the SLP.

Rationale for SLP: Responsible use of herbs

Concern about the safety of herbs and herbal products is one of the most significant issues affecting consumer and healthcare practitioner decisions about use of herbal supplements. Recent survey results show that 50 percent of all consumers are concerned about interactions between supplements and prescription drugs, and 61 percent of herb users are concerned about the same topic.¹ Unless consumers interested in herbal alternatives know where to look for the information, or have a knowledgeable healthcare practitioner with whom they can discuss their questions about herbs, they may have difficulty finding accurate information that explains which herbs are safe for them to use, and how to use them. Likewise, clinicians and pharmacists are increasingly expected to serve as educators when it comes to safety issues. While continuing education on these matters is essential for healthcare professionals, expanded safety information on the label may be an effective part of the overall solution.

Several surveys have suggested that a significant number of people use herbs concurrently with conventional drugs. A Prevention magazine survey a few years ago suggested that about one-third of herb users also are taking either over-the-counter (OTC) or prescription (Rx) drugs.² In a more recent report of 2,590 participants, 81 percent stated that they used at least one medication (Rx or OTC), 50 percent took at least one prescription drug, and 7 percent took five or more drugs simultaneously.³ Fourteen percent said they used herbs and supplements while 16 percent of the prescription drug users also take an herbal supplement. The authors concluded that one in seven adults consumes at least one herbal supplement annually and that one in six patients taking a prescription drug is concurrently taking one or more herbal supplements, raising the potential for interactions.

With the potential for herb-drug interactions increasing, how do consumers and health professionals gain access to reliable information on what constitutes a potential interaction? Many interactions reported in the literature are either theoretical or speculative, often based on in vitro laboratory data or animal studies, which are inconclusive for humans. A recent systematic review of herb-drug interactions concluded that of the 108 interactions evaluated from reports in the medical literature, 74 (68.5 percent) were unable to be evaluated due to the lack of adequate information, 20 (18.5 percent) were considered "possible" interactions, and 14 (13 percent) were considered "well-documented" and thus likely. The authors emphasize the need for better documentation of all relevant data in case studies of potential interactions.⁴

How SLP works

As an independent organization, ABC conducts a literature search on a particular herb, evaluates the data and formulates a review of essential safety information, and then licenses the use of the manufacturer’s version of the ABC information along with the ABC name and logo to qualifying manufacturers. The safety information is initially provided in a format called a Safety Information Sheet (SIS).

The SIS presents a rational interpretation of the literature on the safety of a particular herb, and provides accurate, useful information on contraindications, adverse effects, actual and potential interactions with Rx and OTC drugs, as well as pregnancy and lactation warnings and guidelines. A draft version of each SIS is sent to expert reviewers who check accuracy and clinical relevance. Reviewers’ comments are then evaluated and researched by ABC and may be included in the final version of the SIS.

Each SIS includes information about ABC and disclaimers relating to ABC’s liability (e.g., noting that ABC has neither verified the contents of a herbal package nor tested the product). In addition, after the manufacturer creates its revised safety information based on the SIS for its label, ABC then reviews the proposed label text to determine whether it is accurate and adequately reflects the information in the SIS. This step is required before ABC will allow the label to display the ABC name and logo.

This label text is formatted into a product label, which may include accordion-style labels, peel-out labels, package inserts, or a box panel. In some cases, a manufacturer may decide not to dedicate the extra cost or space required for an expanded label or to minimize the information used on the label from the SIS, instead directing the patients to find more information on the company website where space is not an issue. In all cases, the consumer, patient, and healthcare professional are provided significantly expanded, independent safety information to help promote the safe and beneficial use of herbs.

Sources of safety information

The primary source of information for many of the current SIS is The ABC Clinical Guide to Herbs (The Guide),⁵ a new reference book that includes comprehensive monographs, abbreviated clinical overviews, patient information sheets, clinical studies tables, and extensive references for 29 of the most commonly used herbs and 13 clinically tested proprietary products and herb combinations. ABC also accesses and reviews safety information that is not included in The Guide to help ensure that the SIS accurately reflects a comprehensive view of each herb’s safety considerations. This includes, but is not limited to, various authoritative sources, including official and non-official monographs (e.g., the German Commission E, the European Scientific Cooperative on Phytotherapy, the World Health Organization, and the American Herbal Pharmacopoeia), plus primary references (clinical and pharmacological studies, case reports, etc.), and secondary reference texts and online updates (e.g., Herb Contraindications and Drug Interactions).⁶ For herbs not included in The Guide, ABC researches current literature sources that generally are accepted as reliable by the scientific herbal community, including some of the sources named above.

As part of the ongoing activity of the SLP, key safety information in the SIS will be updated on an as-needed basis, and the updated SIS will be forwarded to participating manufacturers so that they may consider whether to revise their product labels.

It is important to note that, in general, ABC does not believe that there is a safety problem with appropriate use of herbs. However, ABC considers it part of its educational mission to provide consumers and health professionals with accurate guidelines for the responsible use of herbal products.The Guide, provides both extensive guidance information on the therapeutic use of herbs as well as up-to-date safety information. Consumers have expressed their desire for more information on how to use dietary supplements responsibly, and yet manufacturers are not permitted to label and market their products with therapeutic information (i.e., how the product might prevent or treat a disease or condition) beyond the truthful and non-misleading "structure/function" claims allowed by DSHEA. Therefore, ABC considers it appropriate to assist the manufacturer, patient, and clinician in obtaining independent and science-based safety information.

The future of SLP

ABC has reviewed the literature on interactions, contraindications, adverse effects, warnings, and other potential risks in order to clarify their significance (or lack thereof) in each SIS. Ultimately, however, it is the manufacturer’s responsibility to determine the extent of disclosure on a product’s label and in marketing materials. It is the responsibility of the clinician and pharmacist to adequately inform patients about potential risks and interactions associated with herbal supplements, and to work with patients to interpret this information and make rational decisions for individual therapy. It is the responsibility of consumers, many of whom choose to self-medicate, to become better informed about the safety of the products they are considering using to improve or maintain health. As the SLP expands, it may help to facilitate this process for health professionals, manufacturers, patients, and consumers, and may reverse some recent trends by increasing confidence in the responsible use of herbal dietary supplements and related products.

For more information about ABC or SLP contact Wayne Silverman, Ph.D., at <the Development Department>.